POS0305 TIME TO IMPROVEMENT OF FATIGUE IN PATIENTS WITH ANKYLOSING SPONDYLITIS IN A STUDY OF TOFACITINIB
Authors: L. Gossec, D. Cella, J. A. Walsh, R. Sengupta, A. G. Bushmakin, J. C. Cappelleri, A. Yndestad, O. Dina
Journal: Annals of the Rheumatic Diseases (2022)

Background Fatigue is common in patients (pts) with ankylosing spondylitis (AS) and is associated with higher levels of pain and functional disability. 1 Tofacitinib is an oral JAK inhibitor approved for the treatment of AS. In pts with AS, greater improvements in fatigue were seen with tofacitinib vs placebo (PBO). 2 Objectives To estimate the time to improvement in fatigue in pts with AS treated with tofacitinib. Methods This post hoc analysis used data from a Phase 3 trial ( NCT03502616 ) in pts with AS receiving tofacitinib 5 mg twice daily (BID) or PBO for 16 weeks; after Week (W)16, all pts received open-label tofacitinib until W48. 2 Fatigue was assessed by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score (range 0–52; higher scores indicate less fatigue 3 ). A series of time to event analyses were performed using non-parametric Kaplan–Meier models. Median times to initial improvements in FACIT-F total score were assessed based on different thresholds. The initial improvement event was defined as time to first post-baseline week with an improvement in FACIT-F total score of at least 5%, 10%, 15% etc, up to 100%. Median times to events based on absolute changes in FACIT-F total score were also investigated. Results Overall, 269 pts were assessed; baseline demographics/disease characteristics have been previously reported. 2 The median times to initial improvements in FACIT-F total score were significantly (p&lt;0.05) shorter in pts receiving tofacitinib 5 mg BID vs PBO (Figure 1). For example, median time to initial improvement of 30% in FACIT-F total score was 16 weeks in pts receiving tofacitinib 5 mg BID; however, in pts receiving PBO, the median time for this event was not achieved up to W16. More pts receiving tofacitinib 5 mg BID vs PBO experienced initial improvement events up to W16 (Table 1). For example, 36.1% of pts receiving tofacitinib 5 mg BID experienced 50% improvement of fatigue up to W16, compared with 19.9% of pts receiving PBO. Table 1. Proportions of pts who experienced initial improvement events in FACIT-F total score up to W16 Fatigue improvement threshold Initial improvement, n (%) p value a 25% Tofacitinib 5 mg BID 82 (61.7) 0.0009 PBO 58 (42.6) 50% Tofacitinib 5 mg BID 48 (36.1) 0.0031 PBO 27 (19.9) 75% Tofacitinib 5 mg BID 30 (22.6) 0.0626 PBO 19 (14.0) 100% Tofacitinib 5 mg BID 23 (17.3) 0.1233 PBO 15 (11.0) N=133 (tofacitinib 5 mg BID); N=136 (PBO) a Test of equality over strata log-rank test, p&lt;0.05 n, number of pts achieving an initial improvement event; N, total number of pts in each treatment group Conclusion In pts with AS, initial improvements in fatigue, as determined by FACIT-F total score, occurred faster and were larger in magnitude with tofacitinib vs PBO up to W16. These results may help physicians better understand the speed and magnitude for fatigue benefit in pts receiving tofacitinib. References [1]Turan et al. Rheumatol Int 2007; 27: 847-852. [2]Deodhar et al. Ann Rheum Dis 2021; 80: 1004-1013. [3]Hewlett et al. Arthritis Care Res (Hoboken) 2011; 63: S263-286. Acknowledgements Study sponsored by Pfizer Inc. Medical writing support was provided by Lauren Hogarth, CMC Connect, and funded by Pfizer Inc. Disclosure of Interests Laure Gossec Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche and UCB, David Cella Consultant of: AbbVie, Alexion Pharmaceuticals, Astellas Pharma, Bayer, Bristol-Myers Squibb, Clovis Oncology, Evidera, Exelixis, Horizon Therapeutics, Janssen, Merck/Schering-Plough, National Academy of Sciences, Novartis Pharma K.K. (Japan), Pfizer Inc, PledPharma and Regeneron, Jessica A. Walsh Consultant of: AbbVie, Celgene and UCB, Raj Sengupta: None declared, Andrew G Bushmakin Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Joseph C Cappelleri Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Arne Yndestad Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Oluwaseyi Dina Shareholder of: Pfizer Inc, Employee of: Pfizer Inc.